Class II Restorative Kit 5262

GUDID 00883205035721

Class II Restorative Kit

ULTRADENT PRODUCTS, INC.

Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set
Primary Device ID00883205035721
NIH Device Record Key3d4ae23a-72b9-40f0-90aa-f877baeb783f
Commercial Distribution StatusIn Commercial Distribution
Brand NameClass II Restorative Kit
Version Model Number5262
Catalog Number5262
Company DUNS013369913
Company NameULTRADENT PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100883205035721 [Primary]

FDA Product Code

KLEAgent, Tooth Bonding, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-16
Device Publish Date2022-11-08

On-Brand Devices [Class II Restorative Kit]

00883205033048Class II Restorative Kit
00883205035721Class II Restorative Kit

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